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AGC Biologics to Prepare Late Phase and Commercial Runs for Immunocore

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new late-stage clinical and process performance qualification (PPQ) project at its Heidelberg, Germany site with Immunocore Holdings Plc (Nasdaq: IMCR). Immunocore intends to use the Heidelberg site to complete late-stage manufacturing and prepare for commercialization for IMC-F106C, Immunocore’s PRAME-targeted bispecific therapy. Under the agreement, AGC Biologics will leverage its microbial fermentation and manufacturing experience to perform bench-scale qualification and process characterization, and other required studies to support phase III manufacturing, as well as PPQ runs. Pending a successful PPQ campaign and regulatory approvals, the Immunocore project is expected to move into commercial stages at the AGC Biologics Heidelberg site. This is the next step in the partnership for this candidate between the two companies, with AGC Biologics providing early-phase support for this same project. Immunocore and AGC Biologics previously worked together on commercial manufacturing readiness for KIMMTRAK® (tebentafusp-tebn) at the CDMO’s Copenhagen site. “This is a great example of the power of the AGC Biologics network and our ability to collaborate at our global sites to support important client projects,” said Dieter Kramer, General Manager, AGC Biologics Heidelberg. “I am extremely proud of our team here in Heidelberg and the work they’ve done to support this project. We are pleased Immunocore has agreed to work with us on these next important steps in their product’s lifecycle, as our team has the late-stage and commercial expertise to deliver what is needed.” AGC Biologics runs multiple cGMP microbial fermentation lines at its Heidelberg facility. The AGC Biologics Heidelberg site has produced biologics products for 40 years and has built a track record for navigating clients through the early clinical phases and into later stages to help prepare for commercial production. In addition to fermentation, the site serves as a center of excellence for plasmid DNA (pDNA) and messenger RNA (mRNA). To learn more about AGC Biologics’ microbial system-based biologics, plasmid DNA (pDNA) and messenger RNA (mRNA) manufacturing site in Heidelberg, visit www.agcbio.com/facilities/heidelberg. For more information on the company’s Protein Biologics, pDNA, Cell Therapy, Viral Vector and mRNA drug product services go to www.agcbio.com. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com

November 20, 2023 05:08 AM Eastern Standard Time

News Release

Breaking ground in vision restoration: Kiora Pharmaceuticals reveals promising results with KIO-301

Kiora Pharmaceuticals

Kiora Pharmaceuticals CEO Brian Strem joined Steve Darling from Proactive to share news the company's plan to broaden the clinical development of KIO-301, a treatment designed for various inherited retinal diseases. The expansion includes initiating a Phase 2 trial which will be controlled, double-masked, randomized, and will involve an ascending dose. This trial is set to include up to 20 patients suffering from Retinitis Pigmentosa (RP), who will receive doses monthly over a span of 90 days. Strem explained that this move is propelled by encouraging topline results from a Phase I/II clinical trial, which indicated that KIO-301 is a first-in-class small molecule with significant potential to improve vision for patients with RP, even those with extremely low vision or complete blindness. Moreover, Kiora Pharmaceuticals has plans to engage with the FDA in the fourth quarter of 2023. The goal of this meeting is to achieve consensus regarding the study designs, endpoints, and additional requirements necessary to conduct further studies in the United States and Europe. These studies would not only target RP but also extend to other inherited retinal diseases such as Choroideremia (CHM) and Stargardt disease. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:54 PM Eastern Standard Time

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News Release

MTL Cannabis road to success is based on flower first philosophy

MTL Cannabis

MTL Cannabis CEO Mike Perron joined Steve Darling from Proactive to to discuss the ethos and operations of their family-founded company, which places a high value on the quality and potential of the cannabis plant. The company's focus is primarily on flower-based products, including dry flower and pre-rolls. However, Perron notes that they are also venturing into hash production, leveraging their in-house knowledge and capabilities to broaden their product portfolio. Perron highlighted to Proactive the significant growth MTL Cannabis has experienced, attributing it to organic business development strategies. Remarkably, until January last year, the company's sales efforts were spearheaded by a single, highly dedicated sales representative. This individual not only worked with provincial boards but also took personal initiatives to promote the brand to dispensaries and budtenders during weekends. Furthermore, Perron provided insights into MTL Cannabis’s agreement with Canada House Wellness Group, a company deeply rooted in clinics and medical cannabis, originally established by veterans for veterans. The veteran community constitutes a crucial segment of their business, accounting for about 96% of their medical cannabis sales. Canada House operates 12 clinics across the country, including virtual ones, with a strategic presence near military bases to best serve the veteran population. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:44 PM Eastern Standard Time

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News Release

Medicus Pharma sees appointment of Dr Huma Qamar as key to company’s future

Medicus Pharma

In an exclusive interview with Dr Huma Qamar, chief scientific officer for Medicus Pharma Ltd, exciting developments in skincare and oncology are discussed. Dr Qamar shares her passion for addressing unmet medical needs, particularly in the field of basal cell carcinoma. The focus is on SkinJet, a flagship company acquired by Medicus Pharma, utilizing revolutionary microarray needles. The needles, transdermally delivering the chemotherapeutic agent doxorubicin, show promising data in preventing relapse and remission of basal cell carcinoma. Looking ahead, Dr Qamar outlines the company's goals for 2024, emphasizing the resumption of clinical development activities and recruitment efforts. The aim is to complete the phase two trial and present promising data. Dr Qamar, driven by a dedication to oncology and patient well-being, discusses the emotional impact of cancer and the hope that Medicus Pharma's contributions will bring positive changes to the lives of patients. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:21 PM Eastern Standard Time

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News Release

Xeris Biopharma CEO unveils game-changing drug innovations and record financial success

Xeris Biopharma Holdings

Xeris Biopharma CEO Paul Edick joined Steve Darling from Proactive to share insights on the company's focus on innovative drug formulation technology after reporting strong third-quarter results. With three growing products addressing severe hypoglycemia, Cushing's Syndrome, and periodic peripheral paralysis, the company's core lies in commercial success. Edick discussed a promising drug in development—levothyroxine—in a once-weekly subcutaneous injection format, targeting consistency and reduced side effects. Despite being in phase two, the drug could revolutionize current prescription norms. Additionally, partnerships with industry giants like Regeneron and Amgen are underway, emphasizing Xeris' position as a formulation leader. Financially robust, Xeris reported a record quarter and anticipates cash flow breakeven by the fourth quarter. Edick affirmed the company's self-sustainability and projected ending 2024 with ample cash. Despite market challenges, Xeris' growth and strategic focus signal confidence in its trajectory, positioning it as a force in biopharmaceutical innovation. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

November 17, 2023 01:07 PM Eastern Standard Time

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Arecor Therapeutics takes major step with first commercial sale of AT220

Arecor Therapeutics PLC

Arecor Therapeutics PLC CEO Sarah Howell speaks to Thomas Warner from Proactive after the biopharmaceutical group announced the first commercial sale of a product that incorporates its proprietary Arestat technology, known as AT220. Part of a licence agreement with an unnamed global pharma partner initiated in 2017, the milestone has triggered a payment to Arecor. It will also receive royalties on sales. Howell explains the significance of the news, emphasising its importance for patients and the business. She says the achievement aligns with Arecor's vision of building a large, self-sustaining biopharmaceutical company focused on improving patient care. While the partner involved in this achievement remains undisclosed, Howell shed light on Arecor's appeal to pharmaceutical collaborators and says the Arestat technology enables the company to enhance biosimilar products, providing more benefits to patients and giving partners a competitive edge in a high-value market. She says the financial impact is significant, with the milestone triggering licensed payments and initiating recurring royalty streams for Arecor. As the year approaches its end, Howell hints at potential updates. The partnered portfolio shows promising progress, with recent announcements of licensed milestones and positive developments in clinical studies. Ongoing partnerships with pharmaceutical and biotech companies are expected to expand, contributing to Arecor's growth. The company is actively developing its proprietary products, focusing on specialty hospital medications and diabetes treatments. One of their lead diabetes products, AT278, targets patients with high insulin needs, presenting a disruptive solution in a growing market segment. Results from the clinical study are anticipated in Q1 2024. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

November 17, 2023 12:47 PM Eastern Standard Time

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News Release

NRx Pharmaceuticals founder unveils potential treatment for suicidal thoughts and depression

NRx Pharmaceuticals Inc

NRx Pharmaceuticals founder and chief scientist Dr Jonathan Javitt joined Steve Darling from Proactive to discuss groundbreaking developments in treating suicidal ideation and depression. NRx focuses on targeting the NMDA (N-methyl-D-aspartate) receptor in the brain, identified as crucial for turning off suicidal thoughts. Traditional antidepressants, which target the serotonin axis, often increase suicide risk, highlighting the need for a new approach. Javitt told Proactive the company is approaching the clinical trial enrollment goals for its partnered product NRX-101, while opening new clinical initiatives in chronic pain, urinary tract infection, and NRX-100 for suicidal depression. The company said the trial is near completion of enrollment of the originally-targeted 70 participants in the Phase 2b/3 trial of NRX-101. Top-line data from this cohort of patients is expected shortly after the last patient visit. Javitt told Proactive chronic pain affects more than 50 million American adults, compared to the approximately 3 million who report thoughts of suicide on an annual basis. There has been no new non-opioid class of drugs to treat nociceptive pain in the past two decades and NRX-101 has the potential to be the first NMDA-antagonist drug to seek approval for this indication. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 16, 2023 02:07 PM Eastern Standard Time

Video

Navigating Open Enrollment

YourUpdateTV

Open Enrollment season is underway, and as we look ahead to 2024, now is the time to assess health care coverage options and select the plan that is best for you and your budget. Recently, Rhonda Randall, the Chief Medical Officer of UnitedHealthcare Employer and Individual participated in a nationwide satellite media tour to share tips for navigating the Open Enrollment season. A video accompanying this announcement is available at: https://youtu.be/mhpkMs2vBGk Enrollment periods aren’t the same for everyone, so there are key dates to keep in mind depending on your circumstances. Many employers set aside a 2- to 3-week period between September and December when employees can select health benefits for the following year. But just as millions of Americans prepare to choose health insurance for next year, a recent survey revealed that 1 in 3 people (36%) spend less than 1 hour reviewing their benefits options. For most people, not making an enrollment decision means you may be locked into your current plan for the upcoming year. If anything has changed this year – either with your current plan, health status or budget – that decision to do nothing could lead to unpleasant surprises or missed cost-savings in 2024. Because everyone has unique health and budget needs, and there is no one-size-fits-all approach to selecting a health plan, it’s important to stay informed before making these decisions. When choosing a health plan, here are a handful of tips that will hopefully lead to better health and cost savings: Take your time and consider all of your options Learn the language Help prevent financial surprises Check for mental health coverage Don’t forget about specialty benefits Look into wellness programs Explore virtual care services Visit UHCOpenEnrollment.com for tips, resources and information on plans in your area About Rhonda Randall Rhonda L. Randall, D.O., is the Chief Medical Officer of UnitedHealthcare Employer & Individual, the nation’s largest business serving the health coverage and well-being needs of nearly 28 million Americans. Dr. Randall collaborates with U.S. employers who are looking for quality, cost-effective, long-term solutions to health benefits for their employees and retirees. She also leads the clinical strategy development for these businesses to improve quality outcomes, ensure affordability and improve health and well-being. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

November 16, 2023 11:00 AM Eastern Standard Time

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PathAI Announces AISight Support of DICOM Standards and Commits to Being a Leader in Integrated Enterprise Image Architecture and Strategy

PathAI

PathAI, a leading technology company which combines AI-powered pathology solutions with end-to-end central pathology and histology services, today announced that AISight™ [1] supports rendering DICOM® Visible Light (VL) Whole Slide Microscopy Image files. AISight is a state-of-the-art, interoperable, intelligent case and image management system to assist pathologists in the review of digitized whole slide images (WSIs) with a comprehensive menu of fully embedded AI solutions. The incorporation of modern digital pathology into the DICOM standard was finalized in 2010, allowing organizations to integrate digital pathology into their existing IT systems, providing vendor flexibility, and enabling integrated storage with other imaging modalities (e.g., radiology) in vendor neutral archives (VNAs). DICOM support is a major advancement towards enabling PathAI’s vision of interoperable pathology systems that fit seamlessly into providers current or future enterprise image architecture and strategy. “We’ve been collaborating with many large academic medical centers and health systems over the last year to provide consultative support on digitalization of pathology workflows. In these discussions, one thing is clear. Chief information officers (CIOs) and enterprise imaging architects are pushing for vendors to adopt DICOM to drive imaging interoperability,” said Don O’Neill, SVP of Engineering and IT at PathAI. “PathAI is committed to doing just that and being able to render DICOM image files is the first step in that direction.” As part of its investment into DICOM, PathAI is making a commitment to interoperability and providing solutions that integrate with organizations’ enterprise image management and archive strategy, including through VNAs. PathAI will also launch its DICOMweb API in its next release, which will enable AISight to receive DICOM images from external applications, push images back to VNAs leveraging customer’s DICOMweb API, utilize the DICOM file to supplement or validate image/case data, and enable prefetch to pull historical cases/studies directly from image archives. “By investing into interoperability with enterprise image archives, we’re demonstrating to our customers that we are strategically positioned to provide long term value. No matter where a customer is in the imaging journey, we can help them,” said Andy Beck, MD, PhD, co-founder and chief executive officer of PathAI. To learn more about this integration, visit www.PathAI.com or meet with our team at upcoming conferences including Digital Pathology & AI Congress Europe, London (Booth #30, December 7-8). 1- AISight is for Research Use Only. Not for use in diagnostic procedures. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of tissue samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to be a rapidly expanding organization of innovative thinkers from around the globe. For more information, please visit www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

November 16, 2023 10:00 AM Eastern Standard Time

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